On May 13, 2022 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it has received Pediatric Investigation Plan (PIP) product-specific waivers from the European Medicines Agency (EMA) and the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) for cosibelimab in cutaneous squamous cell carcinoma (cSCC) (Press release, Checkpoint Therapeutics, MAY 13, 2022, View Source [SID1234614534]). Following the announcement of positive topline data from Checkpoint’s registration-enabling clinical trial in January 2022, a U.S. Biologics License Application (BLA) submission for cosibelimab is planned for later this year, to be followed by marketing authorization applications (MAAs) in Europe.
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The regulatory processes for the registration of new medicines with the EMA and MHRA require pharmaceutical companies to provide a PIP outlining their strategy for investigating the new medicine in a pediatric population. In some instances, a waiver may be granted by the respective regulatory authority when the development of a medicine for use in children is not feasible or appropriate, as is the case for cosibelimab in cSCC.
"These waivers from the EMA and MHRA are important milestones in the European regulatory process for cosibelimab in cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "Such PIP waivers enable us to proceed more quickly and cost-effectively when advancing our marketing approval applications with the EMA and MHRA, avoiding the significant time and expense required to conduct a pediatric clinical study in Europe. As such, these PIP waivers enhance the value of the cosibelimab program in Europe for Checkpoint and potential partners."
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.
About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) for potential enhanced efficacy in certain tumor types.